Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

HOTLINE Blood and Fluid Warmer Recalled by Smiths Medical ASD, Inc. Due to HOTLINE Blood and Fluid Warmers included Greek and...

Date: October 31, 2016
Company: Smiths Medical ASD, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.

Affected Products

HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

Quantity: 33

Why Was This Recalled?

HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

Where Was This Sold?

Internationally to Finland

About Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report